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Engineering Manager

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TransMedics, Inc.

Sep 11

  • Job
    Full-time
    Senior Level
  • Andover
  • Quick Apply

AI generated summary

  • You need a relevant engineering degree, 7+ years of experience (3+ in leadership), knowledge of medical device regulations, strong project management, and automation skills.
  • You will lead the engineering team, oversee medical device design and testing, manage projects, collaborate cross-functionally, and drive automation initiatives while ensuring regulatory compliance.

Requirements

  • Qualifications:
  • Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field). Master’s degree preferred.
  • Minimum of 7 years of experience in engineering roles, with at least 3 years in a leadership or managerial position within the medical device industry.
  • Strong knowledge of medical device development processes, regulations, and standards (ISO 13485, FDA).
  • Proven track record of managing and delivering complex engineering projects on time and within budget.
  • Significant experience in automation technologies and their application in manufacturing processes.
  • Excellent leadership, communication, and interpersonal skills.
  • Ability to work collaboratively in a fast-paced, cross-functional team environment.
  • Strong problem-solving skills and the ability to make data-driven decisions.
  • Proficient in engineering software and tools (e.g., CAD, FEA, MATLAB).
  • Strong knowledge of medical device regulations (FDA, ISO 13485, etc.).
  • Demonstrated leadership and team management skills.
  • Effective communication and collaboration skills.
  • Familiarity with lean manufacturing principles and continuous improvement methodologies.
  • Commitment to maintaining the highest quality and safety standards.

Responsibilities

  • Lead and manage the engineering team, providing guidance, mentorship, and support.
  • Oversee the design, development, and testing of equipment for the manufacture of medical devices, ensuring compliance with regulatory standards (e.g., ISO 13485, FDA).
  • Develop and implement engineering strategies and processes to improve efficiency and product quality, with a focus on automation and process optimization.
  • Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to drive projects from concept to commercialization.
  • Manage project timelines, budgets, and resources to ensure successful project completion.
  • Conduct performance reviews, provide constructive feedback, and create development plans for engineering staff.
  • Identify and mitigate risks associated with engineering projects and processes.
  • Ensure documentation and technical reports are accurate and comply with regulatory requirements.
  • Stay current with industry trends, technologies, and best practices to maintain competitive advantage.
  • Drive initiatives in automation to streamline manufacturing processes and enhance productivity.

FAQs

What is the main focus of TransMedics as a company?

TransMedics is focused on transforming the standard of care for organ transplantation by increasing organ utilization, improving patient outcomes, and reducing transplant costs.

What are the primary responsibilities of the Engineering Manager for Perfusion Systems?

The Engineering Manager will lead the engineering team, oversee the design and development of medical devices, implement engineering strategies for process efficiency and quality, collaborate with cross-functional teams, manage project timelines and resources, and drive automation initiatives.

What qualifications are required for this position?

Candidates must have a Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field), with a Master's degree preferred. They should also have a minimum of 7 years in engineering roles, including at least 3 years in a leadership position within the medical device industry, along with strong knowledge of regulations and experience with automation technologies.

What is the importance of automation in this role?

Automation plays a crucial role in streamlining manufacturing processes, enhancing productivity, and implementing engineering strategies aimed at improving efficiency and product quality.

Is experience in the medical device industry required?

Yes, candidates need to have a minimum of 7 years of experience in engineering roles, with at least 3 years in a leadership or managerial position specifically within the medical device industry.

What kind of skills are essential for this position?

Essential skills include strong leadership, communication, and interpersonal skills, as well as problem-solving abilities, proficiency in engineering software and tools, and familiarity with lean manufacturing principles and continuous improvement methodologies.

Does TransMedics offer equal opportunity employment?

Yes, TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability, or protected veteran status. They are committed to creating an inclusive environment for all employees.

How does the Engineering Manager support the development of their team?

The Engineering Manager is responsible for conducting performance reviews, providing constructive feedback, and creating development plans for engineering staff to foster their growth and skills.

What regulatory standards must projects adhere to in this role?

All projects must comply with regulatory standards such as ISO 13485 and FDA regulations relevant to medical device development.

Will the Engineering Manager have opportunities for cross-functional collaboration?

Yes, the Engineering Manager will collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to drive projects from concept to commercialization.

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TransMedics, Inc.

Redefining what's possible in organ transplantation

Science & Healthcare
Industry
501-1000
Employees
1998
Founded Year

Mission & Purpose

Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, and clinical care. With more than 25 years of commitment to excellence and innovation, TransMedics is at the forefront of advancing the field of organ transplantation. Our innovative Organ Care System (OCS™) technology is the only FDA-approved technology for lung, heart and liver transplant indications in the U.S., enabling the optimization and assessment of donor organs outside the human body and replacing a decades-old outdated standard of care: static cold storage (ice). Combined with our National OCS Program (NOP), a nationwide team of clinical experts, 24/7 logistics support, and the first-of-its-kind dedicated air & ground transport logistics network, we are enabling transplant centers to expand their search criteria for viable organ donors and grow overall transplant volumes in the U.S.